Wellness Pharmacy, Inc.
Form 483 issued September 30, 2014 · Birmingham, Alabama
- Inspection
- Sep 22 – Sep 30, 2014
- Investigator
- Samantha J. Bradley
- Observations
- 9
- Pages
- 8
- FEI number
- 1037746
In short: On September 30, 2014, FDA issued a Form 483 with 9 observations to Wellness Pharmacy, Inc. in Birmingham, Alabama (FEI 1037746) after an inspection that ran Sep 22 – Sep 30, 2014. The investigator was Samantha J. Bradley. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
I Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter…
- 03
Each batch ofdrug product purporting to be pyrogen-free is not laboratory tested to determine…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
Samantha J. Bradley
14 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
The firmWellness Pharmacy, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wellness Pharmacy, Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Wellness Pharmacy, Inc.?
Samantha J. Bradley is named on this Form 483, for the inspection of Sep 22 – Sep 30, 2014. Each investigator has a profile showing what they cite most.
When was Wellness Pharmacy, Inc. inspected by FDA?
The inspection ran Sep 22 – Sep 30, 2014, and the Form 483 is dated September 30, 2014.
How do I get the full Form 483 for Wellness Pharmacy, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.